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8. Suppose a new cancer therapy is being tested in a large clinical trial. The t

ID: 239919 • Letter: 8

Question

8. Suppose a new cancer therapy is being tested in a large clinical trial. The therapy is working well; it seems that is extending the lives of patients suffering from a deadly form of cancer. But the results are not yet statistically significant. The trial is stopped so that those in the control arm be given the therapy, under the claim that it would not be appropriate to continue to deny them the new therapy. The physicians directing the trial claim that stopping the trial before it provides statistically significant data might in fact delay the therapy's wider use outside of the study. Evaluate stopping the trial from a moral point of view. Be explicit in your use of principles in your answer.

Explanation / Answer

Clinicl trils

Clinicl trils r rsrch studis tht tst nw wys t prvnt, dtct, trt r mng cncr r thr disss. Clinicl trils prvid infrmtin but th sfty nd ffctivnss f nw pprchs t s if thy shuld bcm widly vilbl. Mst f th stndrd cncr trtmnts usd tdy wr first shwn t b ffctiv thrugh clinicl trils.

Prticiptin in clinicl tril my b n ptin fr prsn with cncr r smn t risk fr dvlping cncr. Ppl dcid fr thmslvs whthr r nt thy wnt t prticipt in clinicl tril.

Th imprtnc f clinicl trils

Clinicl trils dd t th prgrss tht is bing md ginst cncr. Thy nswr imprtnt scintific qustins nd ld t futur rsrch. Mny ppl with cncr r nw living lngr bcus f prgrss md thrugh clinicl trils.

Findings frm pst clinicl trils hv ld t:

Typs nd phss                              

Thr r mny diffrnt typs f clinicl trils, including trils fr prvntin, scrning nd rly dtctin, dignsis, trtmnt nd supprtiv cr.

Clinicl trils fr nw trtmnts invlv svrl stps, clld phss. ch phs f clinicl tril nswrs diffrnt qustin but th diss nd its trtmnt.

Cmpnnts f clinicl tril

Clinicl trils fllw vry strict prcdurs nd thicl stndrds tht prtct th prticipnts' hlth, sfty nd privcy. ch tril hs svrl cmpnnts, including its wn prtcl (ctin pln) nd critri fr ligibility. Ppl cnsidring clinicl tril shuld b givn nugh infrmtin but th study (its cmpnnts) t mk n infrmd nd ductd dcisin but tking prt. This prcss is clld infrmd cnsnt.

Bnfits nd risks

Clinicl trils r crfully dsignd t hv s fw risks nd s mny bnfits s pssibl fr vryn wh tks prt. But ch clinicl tril ffrs its wn pssibl bnfits nd risks. It is imprtnt t discuss ths with yur dctr.

Prtctin f prticipnts

Gvrnmnt nd intrntinl rgultins nd plicis r in plc t mk sur tht rsrch invlving ppl is dn ccrding t strict scintific nd thicl guidlins. Clinicl tril prtcls r rviwd by pnl f t lst 5 ppl t th hspitl, clinic r univrsity bfr th tril bgins. Mny clinicl trils ls rquir Hlth Cnd’s pprvl. Th pnl, clld Rsrch thics Brd (REB), includs dctrs, scintists nd mmbrs f th gnrl public. REBs hlp t prtct th ppl wh tk prt in clinicl tril. Thy ls nsur tht th tril is wll dsignd, lgl nd thicl, nd tht it ds nt invlv unncssry risks.

Lctin

A clinicl tril usully tks plc in th sm lctin whr stndrd cncr trtmnt is givn – cncr cntrs, hspitls, clinics r dctrs' ffics. Whil sm trils nrl ppl t 1 r 2 lctins, lrg clinicl tril my invlv thusnds f ppl t hundrds f lctins crss th cuntry r rund th wrld. If prsn livs in smll twn r rurl r, thy my nd t trvl t lrgr city t prticipt in th tril nd tk fllw-up tsts.

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